Systems and methods for providing temperature-controlled therapy

ABSTRACT

Systems and methods provide air or gas-based temperature-controlled medical devices. The systems and methods may be applied to provide therapy to a patient suffering orthopedic or other injuries. Air or other gas is temperature-controlled and adjusted to meet a patient&#39;s physical needs and delivered the patient therapy site through a temperature regulated system including a therapeutic orthopedic wrap. Feedback mechanisms allow the caregiver or the patient to adjust the temperature of the gas. Other fluids may also be used. The systems and methods permit use of electrotherapy for enhanced therapy and injury recovery.

BACKGROUND

Orthopedic injuries and extensive exercise are often accompanied bysignificant tissue swelling and muscle pain, which can lead to long-termand acute injuries. Various technologies have been employed to helpprovide therapy. For example, cold therapy products have long been usedto provide therapy and rehabilitative care for orthopedic injuries. Coldtherapy products include simple ice packs and more sophisticated fluidpumping machines that cool by circulating cold water through atherapeutic wrap. For example, the techniques described by Kolen, et al.(See U.S. Pat. No. 5,980,561) utilize ice water baths and pumpingsystems that pump fluid through orthopedic wraps along a patient'sinjury site to help manage tissue temperature in the site. Suchtechniques help address swelling, edema, and elevated temperatures atthe injury site. Circulating cold water through the orthopedic wrap canhelp manage the swelling as the patient recovers. These techniques havebeen helpful, but they can be cumbersome for patients and physicians touse. For example, many techniques require use of a bucket of ice andcold water. The bucket can be awkward and heavy to transport, which canimpair portability and mobility. Also, as the cold water circulatesthrough the orthopedic wrap and along the patient's injury site, itwarms and returns to the ice bath, where it melts the ice and ultimatelyraises the temperature of the bath. For long-term use, the ice mustregularly be recharged and replaced in order to remain useful inmanaging swelling and temperature at the patient injury site. When thepatient is under the supervision of a caretaker, such as a nurse, thecaretaker must repeatedly add ice to maintain the proper cold therapyfor patients. Additionally, the volume of water corresponding to meltedice must be removed. This regular maintenance adds physical strain tothe patient or caregiver. It can also result in less effective therapydue to temperature variation or lapses in therapy until the ice isreplaced.

Water-based systems have the tendency to leak, spill, or causecondensation at the therapy site. Water at the therapy site increasesthe likelihood of wound infection, and requires more frequent wounddressing changes. Leaks, spills, and condensation can also cause beddingor furniture damage, and in some cases, can damage the therapy system.

Moreover, while the temperature control can be effective in reducingswelling and pain, it does not necessarily address deeper-tissue pain.Deep tissue pain is traditionally treated with electrical stimulationusing electrodes that deliver current to patient tissue. However,electro-stimulation systems are typically not configured for use withcold therapy. For example, water tends to condense around cold surfaces,and when used in conjunction with electrotherapy devices would causecorrosion and rusting around electrical components that would need to beused in electrical stimulation. Water at the electrical components couldalso cause undesirable electrical effects, including changes ofelectrical properties (such as impedance) and the formation ofconductive shunt pathways (such as “short circuits”) between componentsor to other parts of the body to render the stimulation ineffective,uncontrolled, or dangerous. Managing heavy ice buckets along withelectro-stimulation controllers could also be cumbersome.

Improved techniques could be beneficial to the field, particularly asthey provide for a longer, useful life of system components, provide acooling or heating source and controller that are lighter weight,smaller size, and easier to manipulate, reduce or eliminate the risk ofwater at the therapy site, or provide a more compatible interface forcold (or heat) therapy and electrical stimulation systems.

SUMMARY

Systems and methods are disclosed herein that providetemperature-controlled medical devices that use air or other gas as acooling or heating therapy fluid. The systems and methods providetherapy for a patient suffering orthopedic or other injuries. Ingeneral, the systems and methods provide a therapy fluid at a controlledtemperature to meet a patient's physical needs. The fluid is deliveredto the patient therapy site through a therapeutic orthopedic wrap. Thesystems and methods preferably include a temperature regulator andfeedback mechanism to allow the caregiver or the patient to adjust thetemperature of the fluid delivered to the therapy site. The systems andmethods preferably use a gas-based fluid, such as air, that helpsprotect or reduce corrosion around the components of the system and thecomponents of the therapy wrap to help them retain a longer useful life.In certain embodiments, an electrical stimulation module is applied tothe patient injury site and used in combination with thetemperature-controlled therapy to help to further enhance the optionsfor pain management and injury recovery.

In general, a gas delivery system is disclosed for providing therapy toa patient. In certain implementations, the system includes a housinghaving a gas intake port, a means for adjusting and controllingtemperature of the gas within the housing, and a means for deliveringtemperature-controlled gas to a therapy site. Certain implementationsinclude a system for delivering a temperature-controlled gas to atherapy site using a gas temperature regulator, a gas intake port, and acoupling tube, having a first end configured to receive gas from theregulator and a second end configured to deliver gas to a therapy pad ata controlled temperature. The system is configured for use with atherapy pad, having a first surface that mates with the patient'stherapy site and one or more straps or fasteners that connect the pad tothe therapy site. The temperature regulator may be disposed within thetherapy pad to provide an on-board pain management solution. The systemmay also include a tube disposed within the therapy pad and positionedin fluid communication between the temperature regulator and the intakeport. In certain embodiments the intake port is a manifold incommunication with ambient air, and ambient air is used as the fluid forfluid therapy.

In certain embodiments, the temperature regulator is a thermoelectricdevice, such as a Peltier device, and has a cooling component andoptionally a heating component. The system, including the cooling andheating components, may be enclosed in a single housing. The singlehousing includes a first side and a second side disposed opposite thefirst side, the first side having an interface with a first flow tubeand the second side having an interface with a second tube that canreceive fluid from the regulator. The first tube is preferably connectedto the first side to receive fluid from the cooling component, while thesecond tube receives fluid from the heating component. In certainembodiments, the first tube and second tube are joined at a valve andflow into the valve via a first portion of the coupling tube, and thevalve has an output tube comprising a second portion of the couplingtube that connects to the therapy pad.

In certain embodiments the therapy pad has at least one aperture throughwhich fluid is expelled from the pad. The at least one aperture mayinclude a plurality of apertures, and those apertures may be disposedalong a length and width of an inner surface of the pad. The pluralityof apertures could also be disposed within respective ones of aplurality of indentations within the lower surface of the pad. Forexample, the pad surface could have a plurality of indentations in theform of an egg crate pattern with periodic undulations.

Other pad implementations are also contemplated. For example, the padmay be at least partially constructed of foam. It may also be enclosedwithin a frame having gas reliefs that allow gas to flow away from thetherapy site. The pad could also have a diffusion plate disposed betweenthe coupling tube and therapy pad, wherein the diffusion plate isstructured to distribute the gas delivered to the therapy site.

The systems can also be configured for use with an electrode forproviding electrical stimulation therapy. In certain embodiments, asystem includes a connector structured to receive an electrode fordelivering a current to the therapy site. In certain implementations,the connector is positioned on the inner surface of the therapy pad nearor abutting the patient's tissue. The connector may be a female snapreceptacle that receives an electrode having a male fitting for snappingto the receptacle. In certain implementations, the connector is mountedwithin a wall of the wrap. The first surface of the pad may also includeat least one hole through which gas can flow from the temperatureregulator, and the connector can be positioned adjacent the at least onehole so its mated electrode sits within the stream of therapy gas, whichallows the system to provide fluid therapy and electrical stimulation tothe same tissue site.

The systems can be configured with both fluid therapy and electricalstimulation components. In certain implementations, the fluid therapyand electrical stimulation components are configured within the therapypad, providing a fully-integrated, on-board pain management system thatprovides both surface therapy (e.g., via temperature-controlled gas) anddeep tissue therapy (e.g., via electrical stimulation). The on-boardsystem includes a battery or other power source and tubing andelectrical circuitry necessary to power the fluid temperature control,pump the fluid to the therapy site, and provide electrical stimulationto the therapy site.

Other components can also be included. For example, a blower may beprovided to pump the gas to the therapy site. The blower is configuredto deliver gas from the temperature regulator to the therapy site at anyappropriate velocity. For example, the blower may be configured todeliver the gas at a velocity of at least 1 meter per second, betweenabout 2 and about 5 meters per second, or between about 1 and about 10meters per second. In alternative implementations, the blower can beconfigured to deliver the gas at velocities less than 1 meter per secondor greater than 10 meters per second, as determined to be appropriatefor effective temperature regulation of the therapy site.

The system can also be configured for more complex applications. Forexample, heating and cooling could be provided in combination. In thoseimplementations, the coupling tube could include a first coupling tubesection having a first end configured to receive a first gas from thetemperature regulator and a second end configured to deliver the firstgas to a first therapy pad component; and a second coupling tube sectionhaving a first end configured to receive a second gas from thetemperature regulator and a second end configured to deliver the secondgas to a second therapy pad component. The first gas is cooled by theregulator and the second gas is heated by the regulator. The gas couldbe distributed to a plurality of therapy pads. For example, it could beprovided to a first pad configured to mate with a first therapy site;and a second pad configured to mate with a second therapy site on thatpatient (e.g., knee and torso). The pads could be provided to differentpatients, for example a cooling pad could be placed on one patient and aheating pad on another, with the fluid delivered to both being generatedby the same regulator.

In certain embodiments, the temperature sensor monitors the temperatureof the therapy site and delivers electrical signals to the regulator foradjusting the fluid temperature. The temperature regulator has acontroller that receives information from the temperature sensor andtriggers an alarm when a signal from the sensor indicates that thetemperature at the therapy site has reached or exceeded a predeterminedtemperature. The temperature regulator is configured to trigger anautomatic shutoff mechanism when the temperature at the therapy sitereaches a predetermined temperature. In certain embodiments, theautomatic shutoff mechanism is triggered when the therapy has beenapplied for a predetermined amount of time. In certain embodiments, thetemperature sensor is attached to the therapy pad. The temperaturesensor could be an infrared diode or other suitable product.

Improved flow tubing structures are also contemplated. In certainembodiments, a flow structure is configured for delivering atemperature-controlled gas to an orthopedic therapy pad and includes aflow tube with a foam inner surface defining an inner diameter, a foamouter surface defining an outer diameter, and an inner coil beingcoaxial with the tube, the coil having a self-expandable feature. Thecoil is disposed within a portion of at least one of the foam inner andfoam outer surfaces. The structure of the walls reduces flow loss toprovide sufficient air flow velocities. For example, the foam innersurface may be substantially smooth, which allows more efficient flow.The inner coil can be disposed between the foam inner and foam outersurfaces, or have at least a portion of the inner coil located along thefoam outer surface, or at least a portion of the inner coil locatedalong the foam inner surface. The flow tube inner diameter is preferablybetween about 0.25 and about 0.75 inches, or at least between about 0.1and about 2 inches. When used in one or more systems disclosed herein,the tubing mates with a diffusion plate which distributestemperature-controlled gas to a therapy pad.

Other improved flow structures include tubing interconnects for anorthopedic gas delivery device. Example interconnects include a foamtube, having a first foam material and a first aperture, and a foamcoupling having a second foam material and a first end that mates withthe first aperture of the foam tube with an interference fit. The firstaperture of the foam tube has an inner diameter, and the first end ofthe foam coupling has an outer diameter that mates with the innerdiameter of the first aperture. The first aperture of the foam tube hasan outer diameter, and the first end of the foam coupling has an innerdiameter that mates with the outer diameter of the first aperture. Theinterconnects are thermal insulators that enhance thermal efficienciesof the flow circuit by reducing external heat transfer. The first andsecond foam materials could both be insulated foam, and could besubstantially the same foam. For example, the thermal conductivity ofthe thermal insulation materials may be less than about 0.08 watts permeter-kelvin. These structures can also be used in the systems andmethods described herein.

Methods of use and methods of operating a device are also contemplated.Certain methods provide temperature-controlled therapy to a body site bythe steps of receiving gas into a housing, cooling a portion of the gaswithin the housing, and flowing the cooled gas from the housing througha first tube and into contact with a first body site. The methods mayalso include heating a portion of the gas within the housing and flowingthe heated gas through a second tube and into contact with a second bodysite. The cooled gas and heated gas could be mixed in a valve, with themixed gas delivered through a third tube to the body site. The methodsalso contemplate measuring a temperature of skin at a patient body siteduring therapy and sending a signal indicative of the measuredtemperature to a temperature regulator within the housing. Electricalcurrent is then provided to the housing to adjust the temperature of thegas, based on the signal. The gas temperature is adjusted by changing apolarity of a component within the housing based on the temperaturesignal. A thermoelectric temperature control device, such as a Peltierdevice, could be used to heat and cool the gas.

The gas is delivered to the therapy site, preferably directly intocontact with the site through a pad having at least one hole (andpreferably a plurality of holes). The at least one hole is preferablyaligned substantially over and in contact with the first body site sogas can flow to the first site through the one or more holes. Anelectrode can be positioned on the body site (or on multiple bodysites), and the method can include sending electrical signals to thebody site by the electrode while flowing cooled gas to that body siteand the electrode. The same method steps can be performed using heatedgas, including positioning an electrode on a second body site whileflowing heated gas to the second body site. Certain implementations useambient air as the therapy gas.

Methods of controlling the temperature of an orthopedic device are alsocontemplated, including receiving gas in a temperature regulator withinthe orthopedic device; providing an electrical current to thetemperature regulator to adjust temperature of the receiving gas; andexpelling the gas from the orthopedic device after adjusting thetemperature of the gas. The method can include flowing thetemperature-adjusted gas through a plurality of holes in the device,wherein the plurality of holes are exposed to the atmosphere. A portionof the gas may be cooled within the temperature regulator to a firsttemperature below ambient air temperature. A portion of the intake gasis heated within the temperature regulation to a second temperature thatis higher than ambient air temperature. Temperature at a patient site isdetected and a signal is sent to the temperature regulator and comparedto a threshold that identifies a suitable temperature range for theexpelled air.

The systems can be configured with a sterilization unit to providesterilized gas. In certain implementations, the sterilization systemincludes a sterilization device such as an ultraviolet light source, afilter, or an ionization purifier. For example, the ultraviolet lightsource may be a germicidal bulb or an ultraviolet LED. The filter may bea high-efficiency particulate air (HEPA) filter, ultra low penetrationair (ULPA) filter, or activated carbon filter. The sterilization unitmay be coupled to the therapy pad. In certain implementations, thesterilization unit includes a combination of an ultraviolet lightsource, a filter, and an ionization purifier. In certainimplementations, the sterilization unit is coupled to the coupling tube.In certain implementations, the sterilization unit is coupled to thetemperature regulator. The sterilization unit may also be coupled to thegas intake port. In certain implementations the sterilization unit isreplaceable or removable from the system, for example, through a slot ina fluid tube.

The systems can be configured with one or more temperature maintenancepacks. In certain implementations, the temperature maintenance packs arecoupled to the therapy pad, for example, along the bottom surface of thepad. The temperature maintenance packs may be pliable to conform to atherapy site. For example, the temperature maintenance packs maycomprise one of water, glycols, hydroxyethyl cellulose, and silica in asealed, flexible enclosure. In certain implementations, the pad includesat least one aperture positioned above a temperature maintenance pack sothat fluid flows onto the pack after flowing through the at least oneaperture. Certain embodiments of the pad include a plurality ofapertures. The plurality of apertures may be disposed along at least twosides of a temperature maintenance pack.

The systems can also be configured to provide closed-looptemperature-controlled therapy using fluids, such as water. In certainimplementations, the system includes a temperature regulator, a therapypad, having a surface configured to mate with the therapy site, and acoupling tube, having a first end configured to receive fluid from theregulator and a second end configured to deliver fluid to the therapypad at a controlled temperature. In certain implementations, thetemperature regulator is a thermoelectric device, such as a Peltiercooler.

Variations and modifications will occur to those of skill in the artafter reviewing this disclosure, where disclosed features may beimplemented in any combination and subcombinations (including multipledependent combinations and subcombinations), with one or more otherfeatures described herein. The various features described or illustratedabove, including any components thereof, may be combined or integratedin other systems, moreover, certain features may be omitted or notimplemented.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects and advantages will be more appreciatedfully from the following further description thereof with reference tothe accompanying drawings. These depicted embodiments are to beunderstood as illustrative, and not as limiting in any way:

FIG. 1 depicts a control system for adjusting the temperature of atherapy gas in a therapy system for treating orthopedic injuries orother pain or trauma associated with exercise or other physicalactivity.

FIG. 2 depicts an example of a temperature regulator used in a systemfor controlling therapy gas temperature.

FIGS. 3A-3C depict examples of a thermoelectric temperature controlsystem.

FIGS. 4A-4B depict an example of a thermoelectric temperature controlunit and amplitude and frequency information for its application.

FIG. 5 depicts a therapy fluid temperature control system.

FIG. 6 depicts an alternative embodiment of a temperature controlsystem, having heated air mixed with cold air.

FIGS. 7A-7B depict an example of a therapy pad configured for use withair or gas-based therapy fluid system.

FIGS. 8A-8C depict an example of a therapy pad configured for use with agas or air-based fluid therapy in combination with an electricalstimulation system.

FIG. 9 depicts an example of a therapy pad configured for transferringheat to or from an injury site.

FIG. 10 depicts a system for providing temperature control therapy to apatient in combination with electrical stimulation.

FIGS. 11A-11C depict an example of a therapy wrap configured for usewith a gas coolant-based system.

FIGS. 12A-12C depict an on-board therapy control system that combineselectrical stimulation with fluid therapy that istemperature-controlled.

FIGS. 13A-13B depict flow tubing configured to enhance thermalefficiency of therapy gas in a temperature-controlled therapy setting.

FIG. 14 depicts couplings for tubing used in a temperature-controlledtherapy system.

FIG. 15 depicts a garment for regulating skin temperature.

FIG. 16 depicts a temperature regulation garment with an integrated flowchannel.

FIG. 17 depicts an integrated temperature control system within agarment.

FIGS. 18A-18B depict a temperature regulation garment.

FIGS. 19-21 depict methods of sterilizing a gas or fluid.

FIG. 22 depicts a temperature control system with an integratedsterilization unit.

FIGS. 23A-25B depict temperature control systems with temperaturemaintenance packs.

DETAILED DESCRIPTION

To provide an overall understanding of the systems, devices and methodsdescribed herein, certain illustrative embodiments will now bedescribed. The systems and methods disclosed herein provide air or othergas-based temperature-controlled medical devices. The systems andmethods may be applied to provide therapy for a patient sufferingorthopedic or other injuries. For the purpose of clarity andillustration the systems, devices and methods are described with respectto orthopedic injuries or other pain augments. It will be understood byone of ordinary skill in the art that the systems, devices and methodsdisclosed herein may be adapted and modified as appropriate, and thatthe systems, devices and methods described herein may be employed inother suitable applications involving medical device therapy systems andmethods, and that such other additions and modifications will not departfrom the scope hereof.

In general, the systems and methods provide pain and injury managementsystems that use temperature-controlled fluid adjusted to meet apatient's physical needs, and deliver that fluid to a patient therapysite through a temperature regulated system and a therapeutic orthopedicwrap. The systems and methods also preferably include feedbackmechanisms to allow the caregiver or the patient to adjust thetemperature of the fluid delivered to the therapy site. The systems andmethods preferably use a gas-based fluid, such as ambient air, thathelps protect or reduce corrosion around the components of the system,including those around the therapy wrap, to help them retain a longerlife span. In certain preferred embodiments, using air or other gas,rather than water or other heavy liquids, allows an electricalstimulation module to be applied to the patient injury site and used incombination with the temperature-controlled therapy, to help to furtherenhance the options for patient therapy and injury recovery. Controllingmoisture when using electrical stimulation components is necessary forsafe and efficacious therapy.

Certain implementations of the systems and methods are described in thefigures below. These should be viewed as illustrative and not limiting.FIG. 1 illustrates a temperature control system used to control thetemperature of a medical device or therapeutic fluid delivered by amedical device, such as a therapy pad for treating an orthopedic injuryor other muscle, bone or ligament pain. The system 100 includes atemperature regulator unit 102 that receives gas or air from a gassource 104 and adjusts the gas or air temperature to a desired level fordelivery to the patient. The gas source 104 may use, for example,compressed gas or ambient air. As shown, the temperature regulator 102receives the gas through input line 106 at temperature (T₁) and deliversgas through an output line 108 at an output temperature (T₂). The system100 also includes a temperature signal line 103 that is preferably anelectrical line attached to a temperature sensor 132. In alternativeembodiments, the system 100 provides temperature control for liquidfluids, such as water, in place of or in addition to gas temperaturecontrol. The liquid fluid may also be used to treat an injury site, asdescribed herein.

The system 100 is configured to work with a therapy pad 110 forapplication on a patient 114 at an injury or therapy site 112. In use,the gas is input from the gas source 104 and its temperature is adjustedwithin the regulator 102 to output temperature T₂. The gas attemperature T₂ is then delivered to the pad 110 and the temperature ofthe patient's injury site 112 is detected by temperature sensor 132located at or near the injury site 112. The temperature sensor 132 sendselectrical signals by line 103 to temperature regulator 102, the signalsbeing indicative of the temperature at the site 112. Those signals areused to adjust the fluid temperature inside the temperature regulator102, and in turn, the temperature T₂ of gas delivered to the site 112.In preferred embodiments, the temperature T₂ of gas is adjustable, forexample, within a range of 45-65° F.

In certain embodiments, the temperature regulator 102 acts independentlyof the temperature sensor 132. For example, the temperature sensor 132may output the measured temperature to an LED display for the user(patient or caretaker) to see. Alternative embodiments do not include atemperature sensor. For example, the temperature regulator 132 may haveoperational ranges that may be selected by the user. Examples ofselectable operational ranges may include settings for “Cold,” “Warm,”or “Hot” therapy. Alternatively, the temperature regulator may becontrolled by a knob with a continuous selectable range from “Cold” to“Hot” therapy. The patient or user may provide feedback based onpersonal comfort levels and adjust the regulator 132 accordingly.

FIG. 2 depicts an example of a temperature regulator 102, which includesa temperature heating/cooling unit 115 having a cooling surface 118 anda heating surface 120 disposed and configured within a housing 116. Incertain embodiments, the housing 116 is plastic. The temperature controlunit 115 receives gas from the intake 105 through intake tubing 106 (forexample, it could be ambient air or gas from an enclosed tank) anddelivers the gas across one or both of the cooling surface 118 andheating surface 120. In the cooled air example, cooled air from thecooling surface 118 flows out of the control unit 115 and into the flowtube 108, for delivery to the pad. The temperature control unit 115 alsoincludes a second output tube 122 that delivers heated air from thetemperature control unit 115 to either vent in the atmosphere or flowback to the system for subsequent use at the patient site or otherwisewith respect to the patient, as described more fully below. In certainembodiments, a liquid, such as water, flows through intake tubing 106,is heated or cooled at surfaces 118 or 120, and is delivered throughtubes 108 or 122.

In certain implementations the temperature regulator 102 includes aplastic or polymer housing with inner walls, and the temperature controlunit 115 is bolted or nailed or screwed or otherwise connected to thesewalls. The tubing 106, 108, and 122 are joined to the outer surface 102a and 102 b of the temperature regulator 102 and to the walls of controlunit 115 through interface orifices or ports that are disposed acrossthose surfaces. For example, flow tube 108 fits through the wall of thetemperature regulator 102 b across the orifice 117. The tube 108 is alsoconnected on its opposite end to the cooling surface 118 by theinterface port 109. Similarly, the heating surface 120 has an interfaceport 111 (such as a funnel) through which warm fluid flows off theheating element and into the flow tube 122.

The temperature control unit 115 may be structured like a Peltierdevice, having a series of conductive and semiconductive plates throughwhich direct current flows to adjust the temperature of a pair of outersurface plates. An example of a Peltier device 121 is shown in FIG. 3A.As shown, the device includes an N-type semiconductor plate 153 andP-type semiconductor plate 155. The N-type semiconductor plate, whichserves as a carrier of “negative charge,” has mobile electrons forcarrying charge, and is preferably composed of a doped semiconductormaterial such as bismuth telluride or other suitable thermoelectricmaterial. The P-type semiconductor plate, which serves as a carrier of“positive charge,” has vacancies commonly referred to as “holes” forreceiving electrons, and is preferably composed of an appropriatelydoped semiconductor material such as bismuth telluride or other suitablethermoelectric material. In an embodiment comprising a plurality ofsemiconductor plates 153 and 155, the plates are preferably placed in analternating pattern as shown in FIG. 3A. As shown, the plates arepreferably arranged in a parallel configuration relative to each other.The semiconductor plates 153, 155 are disposed between and electricallyconnected by metallic plates 154, 156 such that the current “i” (usingconventional current notation, or “positive current” opposite the flowof electrons e) flows through the lower metallic plate 156 a, thenthrough the P-type semiconductor plate 155, then through upper metallicplate 154 a, then through the N-type semiconductor plate 153, thenthrough the lower metallic plate 156 b. As shown, this arrangement mayrepeat for any number of plates. The current may also be applied in theopposite direction.

The Peltier device 121 is electrically connected to a power source 152within the circuit 150. In use, power source 152 delivers DC current “i”to plate 156 a, which causes a net positive charge to flow via holesthrough the P-type semiconductor plate 155 to the metallic plate 154 aand results in heat flow from metallic plate 156 a to metallic plate 154a to raise the temperature of metallic plate 154 a and lower thetemperature of metallic plate 156 a. Similarly, as the current “i” isdelivered to N-type semiconductor plate 153, a net negative charge flowsvia electrons to the metallic plate 154 a, which results in heat flowfrom metallic plate 156 b to metallic plate 154 a to raise thetemperature of metallic plate 154 a and lower the temperature ofmetallic plate 156 a. In practice, the charge carriers (holes andelectrons) flow in parallel directions and carry heat from one side ofthe device to the other. The device 121 includes heat transfer surfaces118 and 120. As depicted, heat transfer surface 118 is a cooling surfacecomposed of thermal material that abuts lower metallic plates 156 a-156c, and heat transfer surface 120 is a heating surface composed of athermal material that abuts upper metallic plates 154 a-154 b. As anexample, surfaces 118 and 120 are composed of a ceramic material. Inpractice, the surfaces 118 and 120 provide heat storage and heattransfer from the metallic plates 154, 156 for adjusting the temperatureof the delivered gas from temperature T₁ to temperature T₂. The surfaces118 and 120 may also provide electrical insulation from the circuit. Asdepicted, surface 118 has a lower temperature than surface 120. However,either side may be used as a heating side or cooling side dependent onthe direction of the current. Specifically, reversing the polarity ofthe current would result in surface 118 having a higher temperature thansurface 120 because the charge carriers and, in turn, the heat, wouldflow in the opposite direction.

In practice, the temperature of the gas or other fluid is adjusted fromtemperature T₁ to temperature T₂ as it flows across heat transfersurfaces 118 and 120. In certain embodiments, as depicted in FIG. 3B,the heat transfer surfaces include structures to improve the efficiencyof temperature regulation. For example, heat transfer surface 318, whichis similar to surfaces 118 and 120 of FIG. 3A, may have ribs 319. Theribs 319 increase the surface area of surface 318, which providesincreased contact for the gas to interface with the surface 318 to morerapidly and efficiently adjust the gas temperature. The ribs 319 ofsurface 318 may have other structures to improve heat transfer,including ridges, hatching, coils, teeth, and pores.

In the embodiment depicted in FIG. 3C, the heat transfer surface 318includes an enclosure 321. When in place, the enclosure 321 forms closedchannels 322 between the ribs 319 through which the gas or other fluidflows. Enclosure 321 may be formed of a thermally insulating material,such as Styrofoam, polyurethane foam, or other appropriate material toreduce heat exchange with the external environment. Minimizing externalheat exchange improves efficiency, accuracy, and speed in regulating thetemperature from T₁ to target temperature T₂ of the gas or other fluid.The enclosure 321 with channels 322 is particularly useful when heatingor cooling a liquid, such as water to provide controlled flow.

As indicated above, the temperature control unit 115 of temperatureregulator 102 is preferably configured to be in electrical communicationwith the temperature sensor 132 through the electrical line 103. FIG. 4Adepicts a schematic embodiment of a thermoelectric temperature controlunit 115 in communication with the temperature sensor 132. Thetemperature sensor 132 includes at least one of a skin temperaturesensor 133 and an air temperature sensor 136. In certainimplementations, a sensor is provided having both a skin temperaturesensor 133 and an air temperature sensor 136. In certainimplementations, the skin temperature sensor 133 is an (IR) infrareddiode. The IR diode provides the ability to measure skin temperatureindependent of the gas temperature. Additionally, the IR diode is ableto measure skin temperature from thermal radiation without contactingthe

As shown in FIG. 4A, a controller 130, disposed within the electricalline 103, receives an input temperature sensor signal from thetemperature sensor 132 along input electrical line 103, processes thatsignal, and converts it into a digital signal indicative of temperatureat the therapy pad as detected by the sensor 132. For example, thecontroller 130 receives a temperature signal from skin temperaturesensor 133 along line 103 a. The controller may be a microcontroller,processor, or other computing device.

The controller 130 compares the digitized input signal to a thresholdthat may be programmed into the controller for establishing anappropriate and healthy range for the patient's skin temperature, andcreates an output signal along line 103 c that directs thethermoelectric temperature control unit 115 to increase or decrease thevoltage across the voltage source 152, and thereby adjust thetemperature of the gas being delivered from the temperature control unit115. In certain embodiments the controller 130 stores the temperaturemeasurements in storage media that is accessible during or aftertherapy. Storage media may include, but are not limited to, RAM, ROM,PROM (FPROM, EPROM, EEPROM), flash memory, CD-ROM, DVD, or other solidstate memory technology, optical storage, magnetic storage devices, orany other medium which can be used to store the temperature information.For example, the controller may record temperature measurements to amemory card, which can then be accessed by the patient, physician, orother care provider to monitor or adjust therapy.

In cold therapy, it is important that the patient's skin temperature notget too hot or too cold. The target controlled temperature range formaintaining healthy tissue can vary among individuals due tophysiological variability of vasculature, weight, health, type ofinjury, age, and other factors. A typical target temperature T₂ of thegas is 55° F., with a functional range of 45-65° F. In use, thecontroller has programming for an appropriately narrow range oftemperatures that would be acceptable for patient skin, and thetemperature measurements from the temperature sensor 132 are compared tothat range. If the signal indicates a temperature below the lower limitof the range, the temperature of the gas being delivered to the therapypad is preferably adjusted to be warmer. The gas is cooled if the signalindicated a patient temperature that exceeds the upper limit of therange. In preferred embodiments, the skin temperature is monitored, forexample, by an IR diode, and the gas temperature, for example, T₂, isadjusted.

In preferred implementations, a safety mechanism is provided to disablethe delivery of cold therapy gas if the skin temperature reaches apredetermined threshold indicative of hypothermia or other intolerablelevels of skin temperature or cool air exposure. Similarly, if warm gasis being used, upper thresholds are provided that, if exceeded, couldtrigger a shutoff or reduction of the delivery of warm gas.

In certain embodiments, a safety mechanism is provided to limit therapyduration within safe limits. For example, the controller 130 mayautomatically stop therapy after predetermined therapy times, such as a60 minute therapy session followed by automatic shutoff. The controllermay calculate safe therapy durations based on the gas temperature andskin temperature during the therapy session and provide appropriatetherapeutic interventions, including adjusting the gas temperature, orstopping therapy. In certain embodiments, the therapy may be provided incycles, for example, 30 minute therapy sessions followed by 60 minuteresting periods. In certain embodiments, for example, under physiciansupervision, therapy is provided continuously over extended periods upto 48-72 hours or longer as prescribed. Thus minimum, maximum, andtarget temperature ranges and therapy duration are all preferablyprogrammed into the micro controller for controlling the temperature ofthe gas delivered to the therapy pad, and, accordingly, the temperatureof the skin at the patient. In certain embodiments, the safetymechanisms include recording the therapy parameters to storage media,such as flash memory, therapy parameters, may include, for example,duration of therapy, date and time of therapy, skin temperature, gas orfluid temperature, and the date and time of shutoff or other adjustment.

In use, as the controller senses the patient temperature and makesadjustments, the controller adjusts the magnitude, pulse width, orfrequency (or a combination) of the current delivered to the Peltierdevice 121, thereby adjusting the temperature of the surfaces 118 and121 and, in turn, adjusting the temperature T₂ of the gas that exits thetemperature regulator 102. FIG. 4B shows different pulse frequency andpulse widths of example signals that could be delivered to thecontroller. For example, one pulse pattern is shown as signal 142. Ahigher frequency and lower pulse width is shown as signal 144. A lowfrequency, long pulse width is depicted as signal 146.

The temperature of the therapy gas delivered to the patient can becontrolled by using warm or cold portions of the gas that is heated orcooled by the temperature control element 115 and by gas returning fromthe therapy site. FIG. 5 depicts a system 300 for controllingtemperature at the therapy pad similar to the system 100 in FIG. 1. Asshown, cold therapy gas 200 is delivered to the therapy pad by thetubing 108 at the temperature T₂. The gas flows through the therapy pad110 (which is strapped onto the patient 114 via straps 180-184) andexits the therapy pad through the return line 212. The exiting gas 210has warmed to a temperature T₃ because it passed through an injuredsite, which had been swollen and become hot because of the swelling andelevated temperature at the site. The warm gas T₃ flows back into thetemperature regulator 102 and mixes with cold gas within the regulatorand is then delivered back to the pad.

Also shown in FIG. 5, the temperature sensor 132 takes a temperature ofthe gas inside the pad or directly on the therapy site and sends thetemperature control signal 134 back to the regulator 102 for adjustmentof the cold therapy gas 200 temperature T₂ for delivery back to the pad110. The warm therapy gas 214 can be either vented or delivered back tothe patient at another location through venting line 202. In certainimplementations, the warmed gas 214 is sent to a second therapy paddisposed at a different therapy site on the patient, for example aboutthe torso or around the shoulders to capture the heat from the warm gasto warm the patient. In certain embodiments, cool therapy is provided toa first therapy site, such as the knee, while warm therapy is providedconcurrently to a second therapy site, such as the lower back. Forexample, the first injury site may have swelling that can be aided bycooling, while the second injury site may have muscle tightness that canbe aided by warming Concurrent cooling and warming can also provideincreased patient comfort during therapy sessions. For example, somepatients find that cooling therapy at one therapy site is more tolerablewhen warming therapy is simultaneously provided at a second therapysite. In certain embodiments, the second pad is disposed on a differentpatient.

Also shown in FIG. 5 is a blower 250 which is preferably used to pushthe cold gas 200 through the system as well as push the warm gas 214through the system. The blower may be a pump, fan, or other device tomove a fluid. The blower intakes gas at temperature T₁ from theatmosphere (or tank or other source) and blows it across the temperaturecontrol element 115 (see FIGS. 2-4) and thereby moves the gas throughthe system. In certain embodiments, the blower speed, and thus the flowspeed of the gas, is adjustable. Adjusting the flow speed of the gasprovides an alternative or additional means of regulating thetemperature at the therapy site. Increasing the flow speed increases thevolume of air delivered and thus increases the heat carrying capacity ofthe system. In certain embodiments the velocity of the gas is betweenabout 1 meters per second and 10 meters per second, and preferably about3.5 meters per second. However, any appropriate velocity may be used forproviding effective temperature control therapy at the targettemperature. For example, a higher gas velocity may be used for largerinjury sites or for sites with elevated temperatures.

An alternative temperature control system using fluid circulation andmixing is described in FIG. 6. As shown, the cold air 200 and warmed air214 are mixed in mixing valve “V1” prior to delivery to the pad. Thecold air 200 travels through line 108 from the internal cooling elementand the heated air 214 travels through the heating element through thevent line 202 at valve “V2.” The exiting warmed gas can split at valve“V2” and flow down line 202 b, where it is vented, or along piping 202and mixed at the valve “V1.” The mixed air 220 is then delivered to thetherapy pad 110 at the desired pad input temperature. The temperatureregulator 102 can thereby adjust the temperature of the cold air 200that is generated within the regulator, and can also modify thattemperature downstream by the heated air 214 at the mixing valve “V1.”This provides a supplementary process for adjusting the temperature ofthe fluid entering the pad. In some implementations, recirculating ormixing the heated air 214 with the cold air allows the user to morequickly adjust the temperature of the mixed air 220 to moreappropriately suit the patient's temperature needs.

The system described herein provides air or other gas fortemperature-controlled therapy to a patient, which can provideenhancements and advantages over existing technologies. As describedabove, the temperature controls are preferably performed by both thermalelectric processes, such as through voltage changes across a conductivemedium, and also by circulation controls, which allow fine tuning andquick adjustment of therapy fluid. In preferred implementations, the useof air or other gas-based fluids provides additional advantages thatimprove therapy provided to the patient. One advantage is that gas andair can be used in cooling systems that distribute the air or the gasdirectly onto the patient's therapy site, rather than requiring a fullyinsulated wrap, although closed loop systems with fully insulated wrapscan be used. In certain implementations, the orthopedic wrap itself isconfigured to allow the therapy gas to flow directly upon the patient'stissue, thereby providing a potentially drier and more direct source oftherapy control. In certain implementations, such a system allows thecaregiver to integrate other therapy such as electrotherapy.

The systems and methods described herein, including systems 100 and 300,may also provide temperature-controlled therapy of other fluids,including liquids, such as water. The temperature of the liquid can beadjusted to temperature T₂ at the temperature regulator 102, deliveredto the therapy pad through tubing 108, and returned to the temperatureregulator 102 through tubing return line 212, where the temperature canbe appropriately adjusted to target temperature T₂ and re-circulated.The temperature of the liquid may be further controlled using valves todirect mixing, as described in FIG. 6.

The closed-loop liquid system has advantages over conventionaltemperature-controlled therapy systems that use liquids. For example,conventional systems require use of a large reservoir of ice and coldwater. The bucket can be awkward and heavy to transport, which canimpair portability and mobility. Also, as the cold water circulatesthrough the orthopedic wrap and along the patient's injury site, itwarms and returns to the ice bath, where it melts the ice and ultimatelyraises the temperature of the bath. For long-term use, the ice mustregularly be recharged and replaced in order to remain useful inmanaging swelling and temperature at the patient injury site. When thepatient is under the supervision of a caretaker, such as a nurse, thecaretaker must repeatedly add ice to maintain the proper cold therapyfor patients. Additionally, the volume of water corresponding to meltedice must be removed. This regular maintenance adds physical strain tothe patient or caregiver. It can also result in less effective therapydue to temperature variation or lapses in therapy until the ice isreplaced.

System 300 provides temperature regulation through temperature regulator102 that can heat or cool the gas or liquid directly to the targettemperature T₂ without the need for ice. Accordingly, the system 300utilizes a smaller reservoir and smaller volume of liquid, which reducessize and weight for improved portability and ease of use. In certainembodiments, the entire volume of liquid in the system 300 iscontinually circulated between the injury site and the temperatureregulator such that no reservoir is used and a relatively small volumeof liquid is used. For example, the system 300 may require less than1000 milliliters (mL) of liquid, such as water, that circulates toprovide temperature controlled therapy to an injury site. In certainembodiments, the volume of liquid in system 300 is dependent upon thesize of the injury site 112 and the size of the pad (e.g., pad 110)used. For example, a smaller injury site 112 would use a smaller pad 110and a smaller volume of water. In certain embodiments, system 300 mayrequire less than 500 mL of liquid. In certain embodiments, system 300may require less than 250 mL of liquid. In certain embodiments, system300 uses both a liquid and a gas to provide temperature controlledtherapy.

FIGS. 7A and 7B depict an example of a therapy pad configured forsystems that provide cold therapy (or heating therapy) directly to thepatient tissue. As shown, the orthopedic wrap 110 has an inner face 500,outer backing layer 502, support fold 505, and a flow channel 504disposed between the inner face 500 and backing layer 502. FIG. 7Bdepicts a cross-sectional view of the wrap 110 shown along the lineA-A′. As indicated, a plurality of holes 506 are disposed along theinner face 500 of the wrap 110. The holes allow gas 507 to flow from thetemperature regulator (such as regulator 102 through gas line 108) andinto contact with the patient's tissue at the injury site 112. The wrap110 is held to the patient, for example, with support fold 505 aroundthe patient's knee, by a plurality of straps 180 and 182. As shown inFIG. 7B, gas at a therapy temperature T₂ flows into the fluid channel504 from the gas line 108 and, as it travels through the channel, exitsat the various holes 506, providing temperature-controlled gas 507directly to the patient therapy site. This allows for more rapid coolingof the patient than is done by closed systems that require changing thewrap's surface temperature before being able to cool the patient.

As indicated above, the wrap 110 with the one or more holes 506 disposedalong the inner face 500 can be configured to receive and attach one ormore electrodes for providing electro-stimulation (e.g., current,voltage) or other therapy to the patient in combination withtemperature-controlled gas therapy. FIGS. 8A-8C depict an example of thewrap 110 of FIG. 7A-7B configured with electrodes disposed along theinner face 500 of the wrap. As shown, two electrode pairs 510 and 512,respectively, are mounted on the inner face 500. Those electrode pairsconnect to an electro-stimulation unit by wiring disposed within thewalls of the wrap 110. As shown, the electrodes are mounted by male andfemale snap electrode connections (but other techniques can beenvisioned). In particular, a female connector 520 is mounted on theinner face 500 and configured to receive a male electrode snap 522. Themale snap 522 has a button 524 that fits within the receptacle 526 ofthe housing 530 of the female connector 520. When the electrode isconnected to the wall by the snaps, electrical stimulation can beprovided to the injury site 112. At that same time,temperature-controlled therapy gas 507 (which can be heated or cooled)at temperature T₂ flows through the flow channel 504 and is expelled outof the holes 506. As the gas 507 flows out of the holes and onto thetissue site 112 it will contact and surround the electrode male snap522, without corroding the snap 522, as may otherwise occur if water orother liquids were used as the coolant. The flow and circulation of thegas prevents condensation at the electrode, pad, and skin. The cool gasis preferably dry, and therefore can be applied in combination withelectrical stimulation to the patient without corroding or rusting theelectrode, or shorting electrical components.

The flow channel 504 is also structured to allow temperature-controlledgas to flow behind the female connector housing 530 without corrodingthat component. In particular, the female connector housing 530 is sewnor glued into the wall 501 of the inner face 500 of the wrap, and isstabilized within that wall, with the temperature-controlled gas flowingbehind it and remaining within the channel 504.

As the orthopedic wrap 110 is configured to provide both mechanical andelectrical based therapies, the wrap layers 500 and 502 are configuredwith insulated cabling that allows electrical conducting lines to passfrom the electrodes or temperature sensors and out to the controlmechanisms of the system. FIG. 8C is a cross-sectional view of the wrap110 taken along line B-B′ which shows insulated cable 540 extending inparallel with the insulated Cable 542. Cables 540, 542 are both disposedwithin the flow channel 504. Other configurations may also be used, forexample, the cabling may be stitched or configured above or below theflow channel 504 to further isolate the cabling from the flowing gas. Asshown, the insulated cable 540 houses temperature control signal line103, and the insulated cable 542 houses an electrical line that extendsfrom the connector housing 530 of the electro-stimulation electrode andout to an electro-stimulation controller located outside the wrap.

As depicted in FIG. 9, in certain embodiments, the heat is transferredbetween the therapy site and the gas through a heat exchange layer, butthe gas is not delivered directly to the therapy site. Heat exchangewithout air flow to the injury site may be desirable if the gas cancause irritation or desiccation of the site. Flow channel 504 has a heatexchange layer 550, with a surface 554 that couples to the injury site112, and an insulation layer 560. As the gas at temperature T₂ flowsthrough flow channel 504, heat from the therapy site 112 is transferredacross the heat exchange layer 550, thereby reducing the temperature ofthe injury site 112 and raising temperature of the gas to T₃. The gascarries heat away without blowing directly on the injury site. Inalternative embodiments, a temperature-controlled liquid, such as water,flows through channel 508 and exchanges heat across layer 550 with theinjury site 112 to provide cooling or warming therapy without deliverythe liquid directly to the injury site 112.

The heat exchange layer 550 is constructed of a material withsufficiently high thermal conductivity (e.g., greater than about 0.1watts per meter kelvin or “W/m-K”) to allow heat flow between the injurysite and the gas. For example, the heat exchange layer 550 may be foil,Mylar, composite, or any other suitable material. In certain embodimentsheat exchange layer 550 includes texturing or other structures, such asribs 552, to increase the surface area of the heat exchange layer 550and thereby increase the exchange of heat between the injury site andthe gas. The insulation layer 560 acts as a thermal conductive barrierand reduces heat exchange between the external environment and the gasto improve heat exchange efficiency at the therapy site and is typicallycomposed of a material with low thermal conductivity (e.g., less thanabout 0.1 W/m-K). In certain embodiments the insulation layer 560 ispolyurethane. Alternatively, materials with a high specific heatcapacity (e.g., greater than about 2000 joules per kilogram kelvin orJ/Kg-K) may be used as a fluid conductive barrier. For example, theinsulation layer 560 may include propylene glycol.

FIG. 10 depicts a system 600 configured to providetemperature-controlled therapy to a patient in combination withelectro-stimulation therapy. The system 600 is similar to the system 300shown in FIG. 5 (and has similar components to the other systemsdescribed herein) with an added electro-stimulation (“e-stim”) unit 602.In particular, the electro-stimulation unit 602 has a controller 609,connected to a plurality of electrodes 510 by an electrical conductingline 542. For example, the electro-stimulation unit 602 and controller609 may be similar to the Empi Select 1.5, SportX, 300PV, IF3Wave, orActive stimulation units produced by DJO, LLC. As described above, theconducting line 542 can be disposed in insulating cabling within theflow channel of the therapy pad, as shown in FIG. 8C. In operation, theuser can control the temperature of the cold therapy gas 200 flowingthrough the inlet line 108 by operation of the temperature regulator 102and at the same time can control the parameters (current, voltage,magnitude, frequency, waveform, power, etc.) of electro-stimulationtherapy provided to the therapy pad by the electro-stimulationcontroller 602.

While the orthopedic wraps with holes on the interface provide directcontact between the patient and the cooling or heating fluid, otherimplementations of the pad may also be used. FIG. 11A depicts anexploded view of an alternative thermal therapy pad 620 configured foruse in a gas coolant-based system, such as those described above. Asshown, the wrap 620 includes an insulated layer 622 on an upper end anda lower frame 632 having a channel 634 with a series of gas reliefvalves 636 a-636 d disposed about the channel 634 perimeter. A meshlayer 630 is placed between the insulated layer 622 and the lower frame632 to provide a cushioning or ‘standoff layer’ with respect to thepatient to allow adequate flow of the delivered gas around the therapysite. The mesh has a perforated diffusion plate 628 disposed between theupper surface 631 of the mesh layer 630 and the insulated layer 622. Theperforated diffusion plate 628 is overlayed by a connecting ring 624.The connector ring joins to a foam joint tube 626 that receives a distalend of the flow tube 108 coming from the temperature regulator.

In operation, temperature-controlled gas flows through the tube 108 andinto the foam joint tube 626, through the hole 625 disposed in themiddle of the connector ring 624, and then through the hole 623 in theinsulated layer and onto the diffusion plate 628. When the gas contactsthe diffusion plate 628 it disburses laterally as shown by the arrows629 so that it spreads across the upper surface 631 of the mesh layer630 and substantially equalizes the pressure of the delivered gas. Themesh layer 630 is formed preferably in an eggshell or egg crate shapedstructure having a plurality of dense undulations 637 that allow the gasto flow up and down and around the contours of the upper surface 631. Incertain embodiments, a plurality of apertures 635 are disposed withinthe undulations 637, preferably in the bottom well of one or more of theundulations 637. The gas flows through the mesh layer 630 and onto thechannels 634 of the lower frame 632, ultimately purging through therelief valves 636 a-636 d. As the gas travels within the mesh layer 630,it cools the lower surface 633 of the mesh layer 630 opposite the upperface 631 to provide cooling for the patient. The mesh 630 can also bestructured to allow the intake gas to flow through lower surface 633 andthereby directly cool the patient's skin and vent through the reliefvalves 636. Heating can also be applied by simply reversing the polarityon the heating element 115, such as Peltier device 121 or otherwiseproviding a heat source or source of warm gas.

The insulated layer 622 is a soft polymer or other flexible material,such as rubber, polyethylene, or other suitable material. The connectorring 624 is preferably a polymer or thin metal and is positioned underthe foam joint 626 to support the joint 626. A distal end of the joint626 extends through the holes 625 and 623 to connect the joint 626 tothe layer 622 and ring 624 for proper positioning with respect to thediffusion plate.

The perforated diffusion plate 628 has a plurality of holes and istherefore breathable. It is constructed preferably from a perforatedpolymer or thin metal material. In certain implementations, it isconstructed of polyethylene or polyester and is about 0.5 to about 5millimeters thick, preferably about 1 mm-2 mm. In certain embodiments,the mesh layer 630 has an eggshell surface and is foam. In alternativeembodiments, the mesh layer 630 is a wire mesh. The lower frame 632 hasa gasket 640 around its perimeter which helps affix the lower frame 632to the patient. This gasket 640 is preferably constructed of softpolymer that holds the wrap in place and also holds in place anelectrode that may be connected to the lower face of the frame or themesh layer. In certain embodiments, the polymer is adhesive. In thisrespect, the gasket can help eliminate the need for a hydrogel orglycerol gel for attaching a electrode, as the overall wrap itself willbe sticky enough and strong enough to align the wrap on the patient andtherefore align the electrode in its proper position. For example, theelectrode could be sewn or stitched into the wire mesh or into the lowerframe, as shown in FIGS. 8A-8C.

The mesh layer 630 is shown in further detail in FIG. 11B and FIG. 11C.FIG. 11B depicts a top view of the upper surface 631. The undulations637 include a plurality of indent depression structures 660 surroundedby a plurality of ridges 662. Apertures 635 are depicted on the ridges662, but may be disposed on any part of the mesh layer 630. FIG. 11Cdepicts the ridges 662 and depressions 660 in cross section. Inpreferred implementations, the mesh layer 630 is constructed of an opencell foam having a plurality of apertures or may be made of tightlymeshed wire or other material. The ridges 662 and depressions 660 caninclude gaps or spacings between them, as in the case of a wire mesh, toallow therapy gas to flow through and reach the patient.

The therapy temperature control systems described above can be modifiedfor improved patient handling and use, with lower profile and fullyon-board implementations. FIGS. 12A-12C depict an example of a therapywrap housing with a fully on-board temperature control regulator used tocool or heat patient tissue. FIG. 12A shows a side view of a knee wrap700 and FIG. 12B shows the front view of that knee wrap. As shown, aknee wrap 700 (which is similar to the orthopedic wrap system 100described above) includes an on-board temperature control regulator 702that receives gas, such as ambient air or stored gas, through an intakeport 704 and adjusts its temperature by actuating a control knob 701.The gas intake and temperature control components are loaded within thehousing 707, which is self-contained and self-powered, so the patientcan provide cold or warm therapy without needing to carry a large icebath or other cumbersome source of energy or cooling fluid. An electrodeactuator 710 is optionally also included, and the wrap 700 is configuredinside the wrap with an electrode, similar to those discussed above.FIG. 12C shows that the knee wrap 700 in cross section from the inside,with the temperature control regulator 702 fully on board and loadedwithin the layers of the wrap itself. As shown, the temperatureregulator 702 is sewn or stitched within an outer layer 709 of the wrapand delivers gas to the inner mesh layer 630. In certain embodiments,the outer layer 709 has top and bottom surfaces and a thickness, and isconstructed substantially of foam. The regulator 702 includes both anintake manifold 712 and a blower 713 for receiving and pumping ambientair through the system. The intake ambient air passes through an innertube 720 that is also disposed within the outer layer 709, providingfluid communication to the heating/cooling chamber 721 which is equippedwith a heating or cooling element (or both) and a fan. For example, theelement 721 could be similar to heating/cooling element 115 describedabove. The temperature of the air is adjusted within the chamber 721. Itthen passes out of the chamber and through an outlet hole or port 723 inthe outer layer 709 and into the flow channel 650, similar to channel504 within the wall of the wrap. The air then passes through theplurality of apertures 706 in the mesh layer 630 and into the inner area114 of the wrap, where it can contact the tissue of the patient. Thetemperature control of the fluid within the chamber 720 is adjusted bythe knob 701.

Also shown, a plurality of electrodes 512 are configured on the innerface of the mesh layer 630 (or otherwise in the inner face of the wrap700) and can be adjusted to provide therapeutic electro-stimulation byoperation of the electrode actuator 710. A battery 714 is also loadedwithin the control unit 702 to provide an on-board power source foroperating the blower, the temperature control, and the electrodestimulation current control. This structure thus provides a fullyon-board, easy to use and low profile control system that allows thepatient to receive both temperature-controlled therapy and electrodetherapy, including electrical stimulation, to address both surface anddeep tissue pain. Examples of appropriate batteries for this operationcan include 12V lantern batteries with at least 5000 milliampere-hours(mAh) of charge. Rechargeable batteries, including, but not limited to,nickel metal-hydride, lithium polymer, and lead acid batteries incommercially available or custom forms may also be used.

In certain implementations, improved insulated piping and flowstructures are also included. FIGS. 13A-13B depict an example of a flowtube 800 that can be used, for example, as the air flow line 108 of theexamples shown above. This flow tube 800 is preferably made of foam orother insulated material, and it has an outer foam or other insulatedsurface 802 with an inner flow tube i 804. The inner flow tube 804preferably has an inner foam surface 806 that contacts the gas or air asit flows through the tube 800. In certain implementations, the tube 800may have a tendency to buckle or kink and thereby impair the system'scooling or heating functionality. FIG. 13A addresses this by providing aself-expandable inner coil 810 coaxially disposed within the wallsbetween the outer foam surface 802 and the inner flow tube of 804 oftube 800. The coil 810 can be made of Nitinol wire, or other recoilableand expandable material that is self-expandable and yet can retain itsposition under stress. The coil 810 is preferably co-extruded within thetube 800 so that it is disposed within the walls of the tube.Alternatively, the coil 810 can be disposed around the outside surface802, as shown in FIG. 13B.

The inner flow tube 804 has a flow diameter “d1” that is wide enough toallow high pressure air or other gas to flow through the tube. The flowtube surface 806 may be substantially smooth to provide adequate airflow. In certain embodiments, the diameter “d1” may be between about0.25 and about 0.75 inches, and the outer surface may be between about0.25 and about 2 inches, to provide an outer diameter “d2” between about0.5 and 2.75 inches, preferably between about 0.375 and 0.75 inches.However, any appropriate diameters “d1” and “d2” may be used foradequate air flow and thermal insulation. For example, large therapypads or a plurality of therapy pads may required larger tubing forincreased air flow.

Additional insulated structures can also be used to help to conserveenergy and maintain the therapy gas at the desired temperature. FIG. 14depicts an example of a coupling mechanism that can be used to provideinsulation around the connection between the therapy fluid delivery tube108 and the therapy pad, or between the exit of the temperatureregulator and the entrance to the delivery tube 108. As shown, a foamcoupling 830 includes an upper wall 830 a and a lower wall 830 b, with afirst female inner receptacle 831 and a second female receptacle 833structured as apertures. A narrowed passageway 835 is disposed betweenthe two receptacles within the coupling 830. The first receptacle 831receives a male connector end on the line to the therapy pad. Theconnector end 834 of tube 832 fits within the female receptacle 831 by afriction fit. Preferably, the connector end 834 is also made of foamand, therefore, the foam of the inner walls of the receptacle 831 canconnect by friction and stay together with respect to the connector end834. A similar structure is used on the opposite side of the coupling,where female receptacle with foam walls 833 receives the foam connectorend 108 a from the flow tube 108. The passageway 835 is a narrowing inthe flow channel between the upper 830 a and lower 830 b foam walls, andhas a diameter that is smaller than the diameters of either ofreceptacles 831 or 833, respectively.

In practice, the tube 108, tube 832, and coupling 830 are thermalinsulators that enhance thermal efficiencies of the flow circuit byreducing external heat transfer. Tube 108, tube 832, and coupling 830may be insulated foam, and could be substantially the same foam. Forexample, tube 108, tube 832, and coupling 830 may be constructed of afoam material having a thermal conductivity no greater than about 0.08W/m-K, and preferably less than about 0.5 W/m-K. In use, the extensions108 a and 834 are inserted within their respective female receptacles,831 and 833, and are thereby held together by a friction or interferencefit. Temperature-controlled gas is thereby delivered through the tube108 passing through the foam connector ends 108 a through the passageway835 and into the therapy pad. In certain embodiments, the coupling maybe integrally provided with the tube 108 or tube 832.

The systems and methods described herein may be integrated with garmentsto provide temperature regulating garments worn by patients. FIG. 15depicts an example garment 940 that can be worn on the legs of apatient. The garment 940 includes at least one pocket 944 for retainingone or more therapy pads, such as therapy pad 110, disposed within anouter shell 942. The garment 940 depicted in FIG. 15 includes aplurality of pockets 944 a-d. In certain embodiments, the shell 942 isconstructed of a compressive fabric, such as spandex, nylon, polyester,or latex, to provide compression to the injury site and more securelyretain the therapy pad.

The shell 942 of the garment 940 forms at least one sleeve 946structured to wrap around the patient anatomy having an injury site,such as a leg, arm, shoulder, back, or chest. The garment 940 depictedincludes a plurality of sleeves 946 a and 946 b. The garment 940 alsohas an inner area 941, formed by an inner boundary of the sleeve 946,that receives the patent's body. The at least one pocket 944 ispreferably located near or directly on an injury site, such as injurysite 112 of patient 114, and can be structured with an interior webbing,netting, or other porous passageway that interfaces with the pad andallows the gas flowing through the pad 110 to pass through the innergarment wall and into the inner area 941 of the garment 940, where thegas contacts the injury site to help facilitate temperature regulationof the injury site. In certain implementations, the location for placingthe pockets 944 on the garment is customized to the patient and can bedetermined by the location and size of the injury site.

The garment 940 can be configured to deliver gas directly to the injurysite, as previously described. For example, pad 110 may include at leastone hole 506 as depicted in FIGS. 7A-7C and FIGS. 8A-8C or aperture 706as depicted in FIGS. 12A-12C. At least one hole or aperture may belocated in the sleeve 946. In certain embodiments, the garment 940 isconfigured to transfer heat between the injury site and the gas across aheat exchange layer, such as layer 550, as depicted in FIG. 9.

In certain embodiments, the pad 110 is formed as an integrated,self-contained temperature control device, having a cold or hot airgeneration source (for example, a Peltier coil or other examplesdiscussed herein) that can be placed inside the pocket 944. For example,a Peltier-containing housing can be glued or stitched to a pad, such aspad 110, to create a single, hand-held device. The pad is then placed inthe pocket and, when activated, blows cold (or hot) air through thepocket interior surface and onto the patient.

FIG. 16 shows a garment 900 with an integrated flow channel 904 withinthe garment shell 902. At least one flow channel 904 is shown, and insome embodiments, a plurality of flow channels are used. In certainembodiments, the shell 902 is constructed of a compressive fabric, suchas spandex, nylon, polyester, or latex, to provide compression to theinjury site.

The shell 902 of the garment 900 forms at least one sleeve 910, asdepicted sleeves 910 a and 910 b, structured to wrap around the patientanatomy having an injury site, such as a leg, arm, shoulder, back, orchest. In operation, the gas at temperature T₂ enters the channel atentry end 906 and flows through the tubing in channel 904, therebyadjusting the temperature of the injury site. For example, the flowchannel 904 may include at least one hole 506 as depicted in FIGS. 7A-7Cand FIGS. 8A-8C or aperture 706 as depicted in FIGS. 12A-12C to delivergas directly to the injury site. In certain embodiments, the hole oraperture is located in the sleeve 910. In certain implementations, theplacement of the holes or apertures is customized to the patient anddetermined by the location and size of the injury site. In certainembodiments, the flow channel 904 includes a heat exchange layer, suchas layer 550, depicted in FIG. 9 to transfer heat between the injurysite and the gas. The gas flows through the circuit path and then isreleased through exit port 908 at temperature T₃. In certainembodiments, the gas is pressurized, for example, by blower 250, toprovide compression.

FIG. 17 depicts a garment 920 with at least one integrated temperatureregulator 924, which is similar to temperature regulator 102 shown inFIGS. 1 and 2. The garment 920 includes a plurality of regulators 924.In certain embodiments, the temperature regulator 924 includes athermoelectric generator, such as the Peltier device 121 depicted inFIG. 3A. A cable 929 connects the temperature regulator 924 to a powersource, such as a battery or outlet. In certain embodiments, thetemperature regulator 924 is powered by an integrated battery.

In practice, the temperature regulator 924 provides heating or coolingnear the injury site for efficient temperature regulation. In certainimplementations, the location of the temperature regulator 924 iscustomized to the patient and determined by the location and size of theinjury site. In certain embodiments, the target temperature of eachregulator is adjusted independently of other regulators. The temperatureregulators 924 may be flexible in structure to accommodate the contoursof the patient.

In practice, the garment 920 includes an outer fabric or shell 922. Incertain embodiments, the shell 922 is constructed of a compressivefabric, such as spandex, nylon, polyester, or latex, to providecompression to the injury site. The shell 922 of the garment 920 formsat least one sleeve 926, as depicted sleeves 926 a and 926 b, structuredto wrap around the patient anatomy having an injury site, such as a leg,arm, shoulder, back, or chest. Temperature-controlled gas may bedelivered directly within the sleeve 926 to the injury site through atleast one hole or aperture, as previously described, for example inFIGS. 7A-7C, FIGS. 8A-8C, and FIGS. 12A-12C. In certain implementations,the placement of the holes or apertures is customized to the patient anddetermined by the location and size of the injury site. In certainimplementations, heat is transferred between the injury site and the gasthrough a heat exchange layer, such as layer 550 depicted in FIG. 9. Incertain embodiments, the garment 920 includes a plurality of temperatureregulators 924. The plurality of temperature regulators may beoperationally coupled such that the target temperature of each regulatoris substantially the same.

FIGS. 18A-18B depict an additional temperature regulating garment 960shaped like a pair of pants, having at least one sleeve 974. The garment960, as depicted, includes a plurality of sleeves 974 a and 974 b. Thegarment 960 includes an outer layer 962 and an inner layer 964. Thespace 963 between the outer layer 962 and inner layer 964 forms a gaschamber, as shown in the cross-sectional view of C-C′ depicted in FIG.18B. In certain embodiments, the garment 960 includes clasps orfasteners, such as waistband 970 and cuff 972, to hold the garment inplace during therapy. In practice, the gas at temperature T₂ enters thegas chamber 963 of the garment 960 through an entry site 966. Thegarment 960 can be configured to deliver gas directly to the injurysite, as previously described. For example, inner layer 962 may includea hole or aperture or a plurality of holes or apertures, as depicted inFIGS. 7A-7C, FIGS. 8A-8C, and FIGS. 12A-12C. In practice, the hole oraperture is located in the sleeve 974. In certain embodiments, the holesor apertures are placed near or directly over the injury site. Incertain implementations, the placement of the holes or apertures iscustomized to the patient and determined by the location and size of theinjury site.

In certain embodiments, the garment inner layer 964 is a heat exchangelayer, similar to layer 550 depicted in FIG. 9, configured to transferheat between the injury site and the gas. The inner layer 964 isconstructed of a material that allows heat flow between the injury siteand the gas. For example, inner layer 964 may be foil, Mylar, composite,or any other suitable material.

In certain embodiments, the inner layer 964 is constructed of acompressive fabric to provide compression to the injury site. Thematerial also allows heat exchange between the injury site and the gasdue to its material composition and structure. For example, the materialmay be porous, semi-porous, or woven.

In practice, the gas exits the garment 960 through release valve 968 attemperature T₃. Release valve 968 may include one or more valves,apertures, or perforations. For example, garment 960 may include aplurality of perforations distributed across outer layer 962. Inalternative embodiments, the release valve 968 automatically opens whenthe gas in chamber 963 exceeds a predetermined pressure.

In FIGS. 15-18, the garments have been depicted for use on the legs andtorso. However, the garments can be adapted for application to orexclusion of any part of the patient anatomy, including, but not limitedto, the legs, arms, chest, back, shoulders, neck, buttocks, hands, andfeet using the systems and methods described herein. The garments mayalso include electrical stimulation elements, such as electrodes andcontrollers as depicted in FIGS. 8A-8C, FIG. 10, and FIGS. 12A-C. Incertain embodiments, one or more of the temperature regulator, blower,controller, battery, power source, electrical stimulation controller,electrode, or other system elements is integrated on or in the garmentsdescribed above.

Fluids delivered to the therapy site through any of the systems ormethods disclosed herein can be sterilized to prevent infections or thespread of disease. For example, a patient receiving cooling or heatingtherapy may have an open wound at the therapy site or elsewhere on thebody that should be kept clean and free of infectious agents, such asbacteria, viruses, fungi, volatile organic compounds, chemicals, orother airborne pathogens. With water-based therapies, water may leak,spill, or condense at the therapy site and increase the likelihood ofinfection, cause discomfort, or dampen the dressing, which would need tobe changed. Water can also damage furniture, cause electrical componentsto malfunction, or otherwise damage the system or surroundings.

Sterilization systems may be used to address these issues. In general,the sterilization systems include one or more devices positioned withrespect to the therapy systems and methods so as to reduce, deactivate,or eliminate infectious agents in the therapy fluid. In certainimplementations, the sterilization devices are included within or nearthe fluid flow path and contact or apply to the fluid prior to the fluidentering the therapy pad (e.g., within the flow tube that enters thepad). In embodiments where the fluid is gas-based and contacts thepatient directly (e.g., FIG. 7A-8C), sterilization of the gas prior toentering the pad may be particularly important. FIGS. 19-21 illustratedevices and methods for sterilizing a gas or other fluid used in thesystems and methods. FIG. 19 shows a sterilization unit 330 comprising aflow channel 332 through which a gas 334 flows. The flow channel 332includes an ultraviolet (UV) light source 336, such as a UV diode orgermicidal bulb disposed on or about the channel 332 (in this case,disposed about the exterior of the channel wall 333). Preferably, the UVlight source 336 emits light 337 at a wavelength between about 240nanometers (nm) and 280 nm. In certain embodiments, the light source 336emits light 337 at a wavelength between about 150 nm and 200 nm. Thelight source 336 may emit light 337 at a plurality of wavelengths,including, but not limited to approximately 185 nm and 254 nm.

In practice, the gas 334 enters the channel 332 as unsterilized gas 334a. The unsterilized gas 334 a flows along the channel 332 and throughthe emitted light 337 from the light source 336, which kills or rendersharmless microorganisms such as bacteria, viruses, and fungi present inthe unsterilized gas 334 a to provide sterilized gas 334 b. Thesterilized gas 334 b is delivered to the therapy site, such as site 112,as described herein.

FIG. 20 depicts a sterilization unit 340 with a filter 346. The filteris disposed inside the fluid channel 342. The filter 346 trapsparticulate matter, microparticles (i.e., particles having a size lessthan 100 microns), and microorganisms including, but not limited to,bacteria, viruses, and fungi. In certain embodiments, the filter 346includes fibers. For example, the filter 346 may be a high-efficiencyparticulate air (HEPA) filter, ultra low penetration air (ULPA) filter,activated carbon filter, or other filtration system. In certainembodiments, the filter 346 is removable from the system 340, and can becleaned or replaced. For example, the flow channel 342 includes an upperslot 347 that receives a filter, such as the filter 346. The filter 346con be removed and replaced when desired. Filter 346 (or any othersterilization device, for example those discussed or illustrated herein)may be installed within a disposable fluid flow module that can beremovably connected within the tubing or other flow architecture of thetherapy system and disposed after its useful life has expired.

In practice, the gas 344 enters the channel 342 as unsterilized gas 344a. The unsterilized gas 344 a flows along the channel 342 and throughthe filter 346, which traps particulate matter, microparticles, andmicroorganisms such as bacteria, viruses, and fungi. The gas 344 emergesthrough the filter as sterilized gas 344 b. The sterilized gas 344 b isdelivered to the therapy site, such as site 112, as described herein.

FIG. 21 depicts a sterilization unit 350 with an ionization purifier356. The ionization purifier includes electrically charged surfaces 357.As the unsterilized air 354 a flows through the channel 352, theairborne particles and microorganisms are removed from the air 354 a byionization or electrostatic attraction to the charged surfaced 357 toprovide sterilized air 354 b, which is delivered to the therapy site,such as site 112, as described herein. In certain embodiments, theionization purifier 356 produces ozone to purify the gas 354.

The sterilization units may be used in any combination orsubcombinations. For example, air can be purified by combining a UVsterilization unit, as depicted in FIG. 19, with a filtration unit, asdepicted in FIG. 20. Other sterilization methods may also be used,including, but not limited to, photocatalytic oxidation, polarized-mediaelectronic air cleaning, and liquid ionization purifiers.

FIG. 22 depicts a temperature control system with an integratedsterilization unit 360. The sterilization unit may contain one or moresterilization devices, such as the UV sterilization unit 330, filtersterilization unit 340, ionization purifier sterilization unit 3340, orother devices. The temperature regulator 102 is coupled to the flow tube108. In preferred embodiments, the sterilization system 360 is disposedalong the tube 108 near the pad 110 to sterilize the gas immediatelybefore delivery to the pad 110 to ensure that the gas is clean andsterile as it is delivered to the therapy site. In certain embodiments,the sterilization system 360 is coupled to the temperature regulator102. That coupling may be permanent, or modular and removable. Forexample, the sterilization unit 360 may be configured with asterilization device in a disposable module that is installed for usewithin the flow architecture prior to the pad 110 and then is removedwhen the sterilization device has reached the end of its useful life,for example when the filter or purifier is full or a certain amount ofenergy has been emitted by a UV source.

Although primarily described in the context of temperature-controlledgas therapy, the systems and methods described herein may also providetemperature-controlled therapy using other fluids, including, but notlimited to, liquids such as water. For example, the systems and methodsdescribed herein may provide closed-loop, temperature-controlledcirculation systems for liquids.

In certain embodiments, the temperature control system uses one or moretemperature maintenance packs. In certain implementations one or moremaintenance packs are integrated within a therapy pad, such as thosedisclosed herein. FIGS. 23A, 23B, and 23C depict front and crosssectional views (along line A-A′) of an example therapy pad 110configured with a plurality of temperature maintenance packs 511 toprovide cold therapy (or heating therapy) to the patient. In alternativeembodiments, a single maintenance pack 511 is used. As shown, theorthopedic wrap 110 has a flow channel 504 disposed between the innerlayer 500 that forms a lower face of the flow channel 504, and upperlayer 502 that forms an upper boundary or a backing of the flow channel504. The packs 511 are disposed below or along the inner face 500 of thewrap 110 in pockets 515 of the pad 110. In certain embodiments, thepockets 515 partially or fully enclose the packs 511. The wrap 110 isheld to the patient, for example, around the patient's knee, by aplurality of straps 180 and 182. In certain embodiments, the packs 511are pliable and conform to the therapy site. For example, the packs 511may contain a liquid or gel sealed in a flexible enclosure.

As shown in FIG. 23B, the gas 507 at a therapy temperature T₂ flows intothe fluid channel 504 (for example, from the gas output line 108),travels through the channel 504, and contacts the packs 511. Asindicated, a plurality of apertures or holes 506 are in fluidcommunication with the channel 504. The holes 506 are disposed along theinner face 500 of the wrap 110 between the packs 511 and the fluidchannel 504, allowing fluid communication between the therapy gas andthe patients injury site 112. The plurality of holes 506 are preferablydisposed about at least two sides of the temperature maintenance pack.As fluid flows along the channel 504, convection heat exchange 509occurs between the gas 504 and the packs 511, to help provide additionaltemperature control. The holes 506 allow gas 507 to flow along fluidchannel 504 to regulate the temperature of the packs 511. In practice,the packs 511 are placed in pockets 515 near holes 506 so that gas 507can have convective heat exchange 509 with the packs 511. The gas 507flows through the holes 506 and disperse within the interior of the padso the gas 507 contacts the patient's tissue at the therapy site 112(for example as shown and discussed in relation to FIGS. 7A-8C). Incertain embodiments, the gas 507 contacts the pack 511 after exiting thechannel 504.

FIG. 23C depicts an alternative embodiment, in which a temperaturemaintenance pack 511 is disposed near or directly beneath the holes 506such that gas 507 flows throw the holes 506, contacts the packs 511,exits pockets 515, disperses within the interior of the pad 110 tocontact the patient's tissue at the therapy site 112. In practice, thepockets 515 are thermally conductive to allow heat transfer between theinjury site 112 and the temperature maintenance packs 511 for effectivetemperature-controlled therapy of the injury site 112. In certainembodiments, the pockets 515 are permeable to the gas 507.

The temperature maintenance packs 511 preferably have a high specificheat capacity (e.g., greater than about 2000 J/Kg-K) to provide evenheating or cooling to the patient. The packs 511 may include sealedliquids or gels, including, but not limited to water, glycols,hydroxyethyl cellulose, or silica in a sealed, flexible enclosure. Thepacks 511 may be cooled or heated before placement in the pad (forexample, in a refrigerator, freezer, or microwave), and the gas 507flowing around the packs 511 maintains the temperature of the packs 511at the appropriate level. Conventional temperature maintenance packsmust be removed from the therapy site to recharge them to the desiredtemperature. Additionally, conventional temperature packs changetemperature during the therapy session and generally approach roomtemperature, which limits the effectiveness of the temperatureregulation of the therapy site. In contrast, the temperature of thepacks 511 is maintained by gas 507 so that the packs 511 can be usedcontinuously at the desired temperature.

FIG. 24 depicts a cross-sectional view of an alternative embodiment ofpad 110 with a temperature maintenance pack 511 and heat exchange layer513. A plurality of temperature maintenance packs 511 may be used. Thepack 511 is disposed between the inner face 500 and heat exchange layer513 in pocket 517. The gas 507 flows throw the holes 506, contacts thepack 511, exits pocket 517, and disperses along the heat exchange layer513. In certain embodiments, the pocket 517 fully encloses the pack 511.In certain embodiments, the pocket 517 is permeable to the gas 507. Thepocket 517 may be formed as a seam through heat exchange layer 513 andinner face 500.

Heat exchange layer 513 covers the pack 511 and contacts the therapysite 112. Cooling or heating occurs at the patient site by conductionand convection across the heat exchange layer 513. The heat exchangelayer 513 is constructed of a material with sufficiently high thermalconductivity (e.g., greater than about 0.1 W/m-K) to allow heat flowbetween the therapy site 112 and the packs 112. For example, the heatexchange layer 513 may be foil, Mylar, composite, mesh, or any othersuitable material. In certain embodiments, the layer 513 is gas or fluidimpermeable, such that the gas 507 does not directly contact the therapysite 112. The gas 507 is directed back to the temperature regulator(such as to regulator 102 through return line 212) a closed loop forrecirculation. In alternative embodiments, the heat exchange layer 513is at least semi-permeable to the gas 507, and the gas 507 flows throughthe layer 513 to the therapy site 112. For example, the heat exchangelayer 513 may include pores or be constructed of a fibrous or meshmaterial.

FIG. 25A depicts a pad 578 having an aperture 582 for deliveringtemperature controlled gas to the temperature maintenance packs 511. Thepacks 511 are disposed within pockets 519 along the inner face 580 ofthe wrap 578. FIG. 25B depicts a cross-sectional view of the pad 578shown along the line A-A′ of FIG. 25A. The gas 586 at a therapytemperature T₂ flows along tube 584 from the temperature regulator (suchas regulator 102 through gas line 108) and through the aperture 582 toprovide temperature-controlled gas 586 to the packs 511 and maintain thetemperature of the packs 511 at the target temperature T₂. In certainembodiments, the pad 578 includes a heat exchange layer 588, whichinterfaces with the therapy site 112. The heat exchange layer 588 issimilar to previously discussed heat exchange layers 513 and 550, inthat it allows heat to flow by convection and by conduction between thetherapy site 112 and the packs 112. In certain embodiments, the layer588 is gas or fluid impermeable, such that the gas 586 does not directlycontact the therapy site 112. The gas 586 may be directed back to thetemperature regulator (such as to regulator 102 through return line 212)for recirculation. Preferably, the heat exchange layer 588 is at leastsemi-permeable to the gas 586, and the gas 586 flows through the layer588 to the therapy site 112. For example, the heat exchange layer 588may include pores or be constructed of a fibrous or mesh material.

It is to be understood that the foregoing description is merelyillustrative, and is not to be limited to the details given herein.While several embodiments have been provided in the present disclosure,it should be understood that the disclosed systems, devices and methodsand their components may be embodied in many other specific formswithout departing from the scope of the disclosure.

Variations and modifications will occur to those of skill in the artafter reviewing this disclosure, where disclosed features may beimplemented in any combination and subcombinations (including multipledependent combinations and subcombinations), with one or more otherfeatures described herein. The various features described or illustratedabove, including any components thereof, may be combined or integratedin other systems, moreover, certain features may be omitted or notimplemented.

Examples of changes, substitutions and alterations are ascertainable byone skilled in the art and to be made without departing from the scopeof the information disclosed herein. All references cited herein areincorporated by reference in their entirety and made part of thisapplication.

1-247. (canceled)
 248. A system for delivering a temperature-controlledgas to a therapy site comprising: a gas temperature regulator; a gasintake port; and a coupling tube, having a first end configured toreceive gas from the regulator and a second end configured to delivergas to a therapy pad at a controlled temperature.
 249. The system ofclaim 248, wherein the temperature regulator comprises a thermoelectricdevice.
 250. The system of claim 249, comprising a therapy pad, having afirst surface configured to mate with the therapy site;
 251. The systemof claim 250, comprising a blower configured to pump the gas to thetherapy site.
 252. The system of claim 251, wherein the temperatureregulator is disposed within the therapy pad.
 253. The system of claim251, wherein the first surface of the therapy pad is a heat exchangelayer.
 254. The system of claim 253, wherein the first surface has atleast one aperture through which gas is expelled from the pad.
 255. Thesystem of claim 254, wherein the at least one aperture includes aplurality of apertures.
 256. The system of claim 254, comprising aconnector fixed to the therapy pad and structured to receive anelectrode for delivering a current.
 257. The system of claim 256,wherein the connector is positioned on the first surface of the therapypad.
 258. The method of claim 257, wherein the connector is positionedadjacent the at least one aperture.
 259. The system of claim 258,comprising an electrode that mates with the connector.
 260. The systemof claim 259, wherein the electrode, when mated with the connector, ispositioned within a flow stream of gas that exits at least oneaperature.
 261. The system of claim 251, comprising a temperature sensorcoupled to the therapy pad and configured to monitor the temperature ofthe therapy site.
 262. The system of claim 261, wherein the temperaturesensor is an infrared diode.
 263. The system of claim 262, wherein thetemperature regulator has a controller that receives information fromthe temperature sensor and triggers an alarm when a signal from thesensor indicates that the temperature at the therapy site has reached orexceeded a predetermined temperature.
 264. The system of claim 257,comprising a sterilization device.
 265. The system of claim 264, whereinthe sterilization device includes a filter, ultraviolet light source, orionization purifier.
 266. The system of claim 251, comprising a thermalpack.
 267. The system of claim 266, comprising a pocket coupled to thetherapy pad, wherein the thermal pack is disposed within the pocket.268. The system of claim 267, wherein gas is expelled through at leastone aperture onto the thermal pack.